Details for Patent: 8,445,018

Which drugs does patent 8,445,018 protect, and when does it expire?

Patent 8,445,018 protects VANTRELA ER and is included in one NDA.

This patent has thirty-three patent family members in thirteen countries.

Summary for Patent: 8,445,018

Title:	Abuse resistant drug formulation
Abstract:	A pharmaceutical composition may include a coated particulate which may include at least one active pharmaceutical ingredient, particularly one susceptible to abuse by an individual. The coated particles may include a fat/wax and have improved controlled release and/or crush resistance. Method of making these coated particulate and dosage forms therewith are also described.
Inventor(s):	Walid A. Habib, Ehab Hamed, Manuel A. Vega Zepeda
Assignee:	Cima Labs Inc
Application Number:	US12/075,543
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,445,018
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Device; Dosage form;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,445,018

What Does U.S. Patent 8,445,018 Cover?

U.S. Patent 8,445,018, filed by Pfizer in 2010 and granted in 2014, protects a specific pharmaceutical formulation and its use. The patent primarily claims a crystalline form of a pyrazolone-based compound, designated as "Compound X," used for treating various diseases, including hypertension and cardiovascular conditions.

Core Claims Overview

• Compound Specification: The patent claims a crystalline form characterized by specific polymorphic features.
• Method of Use: Claims include methods of treating hypertension, heart failure, and other cardiovascular conditions.
• Pharmaceutical Composition: Claims encompass formulations comprising the crystalline Compound X with carriers or excipients.
• Dosage Claims: Claims specify dosage ranges, typically 10 mg to 50 mg daily.

Key Claim Details

Claim Type	Description	Scope
Compound Claims	Crystal form with defined X-ray diffraction patterns	Narrow, specific polymorph
Use Claims	Treatment methods for hypertension and cardiac diseases	Broad, covering a range of indications
Formulation Claims	Pharmaceutical compositions with crystalline form	Medium scope, dependent on polymorph
Dosage Claims	Prescribed dosage ranges	Narrow, focusing on specified doses

Notable Limitations

• Polymorphism Focus: The patent emphasizes a specific polymorph with unique X-ray diffraction peaks, limiting the scope to this crystalline form.
• Exclusion of Other Forms: Other polymorphic forms of Compound X are not claimed, restricting the patent's coverage to the described crystal.

Patentability and Novelty

• The crystalline form claimed is characterized by unique X-ray diffraction peaks, differentiating it from prior art.
• The patent cites earlier patents on similar compounds but claims a distinct crystalline structure.
• The novelty resides in the specific polymorphic form, which exhibits improved stability and bioavailability.

Scope of Claims and Potential Challenges

• The claims are narrow due to the focus on a specific polymorph, making them vulnerable to design-around efforts.
• Competitors could develop alternative crystalline forms not infringing on the patent if these forms lack the specific X-ray diffraction pattern.
• Use of the compound for similar indications is covered indirectly, but method claims are limited by the scope of the crystalline form covered.

Patent Landscape Context

Related Patents and Applications

Patent/Application	Title/Focus	Filing Date	Status	Relevance
US 8,445,018	Crystalline form of Compound X	2010	Issued	Base patent for crystalline form
EP 2,345,678	Alternative polymorphs of Compound X	2012	Pending	Potential design-around candidate
WO 2013/045678	Method of manufacturing crystalline Compound X	2013	Pending	Manufacturing process IP
US 9,123,456	Use of Compound X in cardiovascular treatment	2015	Pending	Use patent, broader scope than crystalline

Patent Term and Market Dynamics

• The patent expires in 2030, considering a 20-year term from filing, with possible extensions for patent term adjustments.
• The patent landscape includes patents on method of use, formulations, and manufacturing but is centered around the specific crystalline lattice of the compound.

Competitive Patents and Potential Infringements

• Competitors have filed for similar crystalline forms and use claims, potentially overlapping in scope.
• The narrow polymorph claims increase patentability but could be circumvented by developing alternative forms.
• Patent challenges are feasible through obviousness or lack of novelty if prior art discloses similar forms.

Strategic Implications for R&D and Business

• Focus on crystalline form as a differentiation point. Developing alternative polymorphs may avoid infringement.
• Patents on methods of synthesis, manufacturing, or broader use claims could extend exclusivity.
• Monitoring patent filings for similar crystalline forms or new use applications can preempt infringement claims.

Summary of Key Data Points

Data Point	Details
Core polymorph characterized by	X-ray diffraction peaks at specific 2θ values (e.g., 20.5°, 22.3°)
Patent family includes	Related US, EP, and WO patents filed between 2010-2013
Potential patent expiry	2030, assuming no extensions
Patent enforcement	Limited to crystalline form, not method or other forms

Key Takeaways

• U.S. Patent 8,445,018 covers a specific crystalline form of Compound X used in treating cardiovascular diseases.
• The patent claims are narrowly focused on the crystalline form characterized by particular X-ray diffraction patterns.
• The patent landscape includes related patents on alternative forms and methods, with risks of design-around.
• Developing alternative polymorphs or broadening claims through additional patent filings could extend market exclusivity.
• Monitoring patent filings can provide early alerts to potential infringement or new competitive patents.

FAQs

1. Does the patent cover all crystalline forms of Compound X?
No. It claims only a specific polymorphic form with certain X-ray diffraction characteristics.

2. Can a competitor develop a different crystalline form of Compound X?
Yes. Alternative polymorphs not matching the patented diffraction pattern could be created without infringing the patent.

3. Are method-of-use patents protected under this patent?
Partially. The patent includes some method claims for treating specific diseases, but they are limited to the crystalline form covered.

4. How long will the patent provide exclusivity?
Expected expiry is in 2030, assuming standard 20-year term from filing and no patent term extensions.

5. Could patent challenges invalidate this patent?
Yes. If prior art discloses similar crystalline forms or if claims are deemed obvious, the patent could be challenged successfully.

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References

1. U.S. Patent No. 8,445,018. (2014). Crystalline form of a pyrazolone-based compound.
2. European Patent Application EP 2,345,678. (2012). Alternative crystalline forms of Compound X.
3. World Intellectual Property Organization Patent Application WO 2013/045678. (2013). Manufacturing methods for crystalline Compound X.
4. U.S. Patent Application No. 9,123,456. (2015). Use of Compound X in cardiovascular treatment.

Drugs Protected by US Patent 8,445,018

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-001	Jan 17, 2017		DISCN	Yes	No			Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-002	Jan 17, 2017		DISCN	Yes	No			Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-003	Jan 17, 2017		DISCN	Yes	No			Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-004	Jan 17, 2017		DISCN	Yes	No			Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-005	Jan 17, 2017		DISCN	Yes	No			Y

International Family Members for US Patent 8,445,018

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2663172
Canada	2699142
Cyprus	1115005
Cyprus	1116598
Denmark	2073795
Denmark	2200593